The board of directors of the Company (the “Board”) is pleased to announce that the Group has recently received a notice from the National Institutes for Food and Drug Control of the PRC (中國食品藥品檢定研究院) on the serum antibodies test results of Phase III clinical trial of iterative serum-free rabies vaccine. To date, the unblinding and statistical analysis work for data of Phase III clinical trial of the iterative serum-free rabies vaccine of the Group has been completed. The research results showed that the iterative serum-free rabies vaccine developed by the Group has good immunogenicity and safety and has met the pre-defined clinical objectives.

The board of directors of the Company (the “Board”) is pleased to announce that the Group has submitted the official application to the Center for Drug Evaluation (CDE) of National Medical Products Administration of China for clinical trials for quadrivalent influenza virus vaccine (MDCK Cells) in August 2024. Currently, all influenza vaccines available on the domestic market are produced using chicken embryo technology. There have not been cell-based influenza vaccines approved for marketing. Organizations such as the World Health Organization, the U.S. Food and Drug Administration, and governments of several countries worldwide advocate for the adoption of animal cell culture technology to replace the traditional chicken embryo technology in production of influenza vaccines.

The board of directors of the Company (the “Board”) is pleased to announce that the official application for clinical trials for the Group’s absorbed tetanus vaccine has been submitted to the Center for Drug Evaluation (CDE) of National Medical Products Administration of China in August 2024. The research and development of the vaccine is in line with the Company’s strategic layout in product research and development and is an important step to realize the Company’s research and development of multidisease and multivalent products, which will further improve the Company’s product pipelines, help the Company consolidate its industry position in the field of vaccines not covered by the immunization programs (Class II vaccine) in China, and contribute to the sustainable development of the Company’s vaccine business.

Following the established corporate strategy, the Group proactively advances the development of the vaccine product pipelines, and leverages the advantages of the mRNA technology platform to accelerate the research and development of mRNA vaccine series products through on-going technological innovation. In August 2024, the Group has submitted pre-applications for clinical trials for mRNA RSV (respiratory syncytial virus) vaccines and mRNA shingles/herpes zoster vaccines to the U.S. Food and Drug Administration (“FDA”).

Vice President and Chief Research Officer Zhang Fan, and General Manager of AIM Lifanda Peng Yucai, recently published the preclinical research data of the mRNA rabies vaccine LVRNA001 in the international authoritative academic journal "npj Vaccines": Only two vaccinations are needed to provide 100% safe and effective immune protection. This has laid a solid foundation for the next stage of research on human rabies mRNA vaccines.

Following the established corporate strategy, the Group proactively advances the development of the vaccine product pipelines, and leverages the advantages of the mRNA technology platform to accelerate the research and development of mRNA vaccine series products through on-going technological innovation. In June 2024, the Group has submitted pre-applications for clinical trials for mRNA respiratory syncytial virus (RSV) vaccines and mRNA shingles/herpes zoster vaccines to the Center for Drug Evaluation of National Medical Products Administration.

The board of directors of the Company (the “Board”) is pleased to announce that the Group has submitted the pre-application for clinical trials for haemophilus influenzae type b (Hib) conjugate vaccine on March 27, 2024, and the pre-application for clinical trials for absorbed tetanus vaccine on February 9, 2024. The research and development of these two vaccines is in line with the Company’s strategic layout in product research and development, is an important step to realize the Company’s research and development of multidisease and multivalent products, and will further improve the Company’s product pipelines.

The board of directors of the Company (the “Board”) is pleased to announce that the Group has submitted the pre-application for clinical trials for quadrivalent influenza virus vaccine (MDCK Cells) on March 27, 2024. Currently, all influenza vaccines available on the domestic market are produced using chicken embryo technology. There have not been cell-based influenza vaccines approved for marketing. Organizations such as the World Health Organization, the U.S. Food and
Drug Administration, and governments of several countries worldwide advocate for the adoption of animal cell culture technology to replace the traditional chicken embryo technology in production of influenza vaccines.

The board of directors of the Company (the “Board”) is pleased to announce that the Group has submitted the pre-application for clinical trials for novel-process highly-effective human diploid rabies vaccine on March 24, 2024. Currently, there is a lack of effective clinical treatment for rabies, and therefore post exposure prevention is crucial. The main preventive measures are inoculation of human rabies vaccine and injection of passive immunization agents. The human diploid cell rabies vaccine has natural safety advantages and a broad market space.